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Exelixis axes staff as lead cancer programme fails

Plans to cut workforce by 70% after cabozantinib disappoints in phase III
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Exelixis has said it will have to cut its workforce by 70% after its lead drug cabozantinib failed to meet its objectives in a phase III trial.

The company intends to let 160 workers go, retaining just 70, in order to buy time to bring its other pipeline projects through to fruition. The redundancies will cost the company between $6m and $8m and most will occur before the end of the year.

Cabozantinib was unable to show any survival benefit compared to prednisone in the COMET-1 trial, which enroled men with metastatic, castration-resistant prostate cancer (mCRPC) whose disease had progressed despite prior treatment with docetaxel as well as Johnson & Johnson's Zytiga (abiraterone) or Astellas/Medivation's Xtandi (enzalutamide).

Cabozantinib - which acts as a c-MET and VEGFR2 inhibitor - is already approved as Cometriq for the treatment of progressive, metastatic medullary thyroid cancer (MTC) in the US and Europe, but sales in this rare disease are small - around $12m in the first half of the year - and Exelixis was counting on the much larger CRPC indication to boost growth of the drug.

In the latest trial, median overall survival for cabozantinib was 11 months compared to just below 10 months for prednisone, which was not a statistically significant improvement.

Exelixis' drug did a little better on progression-free survival - boosting it to 5.5 months from 2.8 months for the control drug - but while this was statistically significant it was not the primary outcome measure in the trial.

The company clearly thinks this efficacy signal is not compelling enough to take cabozantinib forward as it has also halted a second phase III trial looking at pain palliation in prostate cancer as well as a phase II combination study with Zytiga.

All eyes at Exelixis are now on the outcome of trials of cabozantinib in kidney cancer (METEOR) and liver cancer (CELESTIAL), which are due to generate results in 2015 and 2017 respectively.

There had been some indications all may not be well with COMET-1 when the company indicated in March that the trial was not going to be stopped early - as some had hoped - and would be continuing to its scheduled conclusion.  

Shares in the company have fallen more than 40% over the last six months as investors voiced concerns that without truly compelling data cabozantinib would struggle to break into a market already revitalised by the recent introductions of Zytiga, Xtandi and Bayer's radiopharmaceutical Xofigo (radium Ra 223 dichloride).

Article by
Phil Taylor

2nd September 2014

From: Research, Sales



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